Update on China-Denmark Food and Drug Regulatory Cooperation Centre

Transcription

1 Update on China-Denmark Food and Drug Regulatory Cooperation Centre Stakeholder meeting, 7 December 2017 Jakob Cold, Deputy Director General

2 State of Play China-Denmark Drug Administrative Law Exchange Forum Visit from CFDA/CFDI on 9-10 October 2017 Course in Chinese cultural understanding China-Denmark Inspection Exchange Forum November 2017 Exchange on Joint Working Programme Development of Inception Project to Strategic Sector Cooperation on Health in China 2

3 China-Denmark Drug Administrative Law Exchange Forum High-level CFDA/CFDI delegation visit at DKMA 9 October 2019 Agenda Status of revision of Drug Administrative Law Authorisation of medicines MAH concept Danish regulation of manufacturing and distribution of medicines Medicines inspection Accountability Compensation for medicinal injury (Patient Compensation Association) Regulation of herbal medicines in EU 3

4 Key messages on Chinese DAL reform (1) Context: From generics-oriented to the combination of innovative drugs and generics and from a big pharmaceutical country to a strong pharmaceutical country Drug Manufacturers: 4176 Drug Distributors: Total output of healthcare industry: trillion Chinese Yuan Total sales of healthcare products: billion Chinese Yuan Import of healthcare industry: 55.1 billion Chinese Yuan Export of healthcare industry: 48 billion Chinese Yuan 4

5 Key messages on Chinese DAL reform (2) Overall prevention and control of risks Overall fulfillment of responsibilities Overall promotion of systems Overall improvement of capabilities Mission of regulators: Protect and promote the health of the public Biggest risk to public health: No therapy for the disease 5

6 Key messages on Chinese DAL reform (3) Basic principles Drug administration shall be patient-centered, based on risk-benefit evaluation and adopt life scientific and strict life-cycle management Drug administration shall be patient-centered, based on risk-benefit evaluation and adopt life scientific and strict life-cycle management. Innovation: Systems go from passive to proactive Regulation go from traditional to modern Foster a self-discipline industry without too much regulation 6

7 Key messages on Chinese DAL reform (4) Issues to be discussed about MAH: The division of responsibilities between MAH and CMO The division of responsibilities between the local regulator and the regulator where the MAH is located when the CMO is not at the same location with the MAH The relationship between MAH and retailers Clinical trial: Change the approval system into filing system for CT sites Change from approval system into acquienscence system for CT programmes Manufacturing: From certification to inspection, from standards to system 7

8 Key messages on Chinese DAL reform (5) Conclusions: Company takes primary responsibility Government regulatory system Co-governance with society To be scientific-based, risk-based regulation To be society-based, social co-governance To be politially-based, shared responsibility Radical change of regulatory system? 8

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10 Visits 10 October 2017 Sønderbro pharmacy Pharmacy regulation Pharmaceutical price system Regulation of prices Substitution Tjellesen Max Jenne Pharmaceutical distribution in Denmark Safety and quality in the supply of pharmaceuticals Interaction with DKMA 10

11 China-Denmark Inspection Exchange Forum 3 DKMA inspectors in Beijing for Exchange Forum November participants from CFDI and provincial inspectorates 80 GMP inspectors and 20 GCP inspectors Agenda General intro to management of inspectorate General intro to GMP, GCP and data integrity inspections Workshops on GMP inspections and GCP inspections with data integrity incorporated Well-received, good interactions, many questions 11

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15 Exchange on Joint Working Programme (1) Aim to sign Joint Working Programme before end of year Feedback from CFDA and subordinate agencies early November Generally acceptable, but include medicines assessment training, GCP inspections and microbiological testing Revised draft Joint working Programme sent late November to CFDA Not include microbiological testing due to lack of DKMA expertise 15

16 Exchange on Joint Working Programme (2) 2018 activities, e.g. Pilot projects medicines evaluation exchange Testing of radiopharmaceuticals Workshops on Innovative Medicines: Clinical assessment Biological and biosimilar medicines Workshop on assessment of clinical trials, including scientific advice Visit to DKMA for inspectors with observed GMP inspection 16

17 Cooperation from stakeholders needed Use (old) dossiers for pilot projects on medicines evaluation exchange Accept from MAHs to use dossiers Assistance in selecting relevant dossiers Observed GMP inspection Q Chinese observers Extra ressources required from inspected company Contact persons? 17

18 Next steps Signature of Joint Working Programme Scheduling activities of 2018 Implementation of Inception Projects and other activities Workshop on Chinese regulation of medical devices 18

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